Medtronic Biopsy Needle FPU Kit Recalled for Depth Stop Issue
Medtronic Navigation is recalling Biopsy Needle FPU Kits because the depth stop may not tighten securely, potentially causing surgery delays.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the stated hazard is a delay in surgery rather than a direct risk of serious injury or death, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Medtronic Navigation, Inc. is recalling the Biopsy Needle FPU Kit, Product # 9736075, UDI: 00763000063108. The recall involves one disposable biopsy needle per kit. The affected lot numbers are 0009754921, 0009921274, 0009940846, 0009921273, 0009921276, and 0009952564.
The recall was initiated due to a manufacturing issue affecting the biopsy needle depth stop. The firm has determined that some depth stops may not tighten securely to the biopsy needle when tightened. This defect could result in a delay in surgery. The source text does not report any injuries, illnesses, or deaths associated with this issue.
The product was distributed in all 50 U.S. states, the District of Columbia, and numerous international locations including Australia, Canada, China, and the United Kingdom. Healthcare providers and facilities that have received these kits should stop using the affected units and contact Medtronic Navigation for instructions on return or replacement.
The recalled product
- Product
- Biopsy Needle FPU Kit, Product # 9736075, UDI: 00763000063108
- Manufacturer
- Medtronic Navigation, Inc.
- Affected units
- 1
Distribution
Part of a larger recall action
This product is one of 3 recalled by Medtronic Navigation, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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